Keytruda Granted Priority Review for Hodgkin Lymphoma

Keytruda was granted a priority review to a supplemental biologics license application (sBLA) to treat a subset of patients with classical Hodgkin lymphoma.
BY JASON M. BRODERICK @jasoncology
Keytruda (pembrolizumab) was granted a priority review to a supplemental biologics license application (sBLA) by the U.S. Food and Drug Administration (FDA) for the treatment of patients with refractory classical Hodgkin lymphoma (cHL) or who relapsed after three or more lines of therapy, according to a statement from the manufacturer of the anti-PD1 agent, Merk.

The application is based on results from the phase 2 KEYNOTE-087 and phase 1b KEYNOTE-013 trials, which evaluated Keytruda for the proposed indication in the sBLA. The specific regimen would be a fixed dosed of 200 mg of Keytruda every three weeks.

If approved, this would be the first FDA indication for Keytruda in a hematologic malignancy. The PD-1 inhibitor previously received a breakthrough therapy designation for cHL in April 2016. Under the priority review, the FDA is scheduled to make a final decision by March 15, 2017.

“Patients with refractory or relapsed classical Hodgkin lymphoma have limited treatment options,” Roger Dansey, M.D., senior vice president and therapeutic area head, Oncology Late-Stage Development, Merck Research Laboratories, said in a statement. “We believe that the expedited review of this sBLA granted by the FDA is an important step in helping us make Keytruda available as quickly as possible to patients living with this disease.”

Findings from the KEYNOTE-087 study showed overall response rates (ORRs) of about 70 percent to 80 percent in three separate cohorts of relapsed/refractory Hodgkin lymphoma patients, including patients who relapsed after treatment with Adcetris (brentuximab vedotin), patients who failed to respond to Adcetris, patients who relapsed or progressed after autologous stem cell transplant (ASCT), and those ineligible for ASCT.

KEYNOTE-087 was a multicenter, single-arm, nonrandomized study of Keytruda in three cohorts of patients with relapsed/refractory cHL. Cohort one included patients who failed to achieve a response to, or progressed after ASCT, and relapsed after treatment with or failed to respond to Adcetris post ASCT. Cohort two included patients who were unable to achieve a complete response (CR) or partial response (PR) to salvage chemotherapy and did not receive ASCT, but relapsed after treatment with or failed to respond to Adcetris. Finally, cohort three included patients who failed to achieve a response to or progressed after ASCT and did not receive Adcetris post ASCT.

Study participants were treated with Keytruda, 200 mg intravenously every three weeks on day one of each 21-day treatment cycle for up to 24 months. A flat dose was chosen because of the flat exposure-response relationship for efficacy and safety in the 2-mg/kg to 10-mg/kg dosage range across prior clinical studies.

A prespecified interim analysis, based on investigator-assessed response, was performed after 30 patients reached first response assessment in all three cohorts. The percentage of patients receiving greater than three prior lines of therapy was 73 percent in cohort one, 60 percent in cohort two, and 37 percent in cohort three. The median number of lines of systemic therapy was five, four and three in each cohort, respectively. By design, all patients in cohorts one and two had prior Adcetris failure, as did 40 percent in cohort three.

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